The iNPH Patients Scheduled for VP or LP Shunt ProceduresNCT05183061
Factors Associated With Post-induction Hypotension in iNPH Patient Undergoing VP and LP Shunt
An observational study of The iNPH Patients Scheduled for VP or LP Shunt Procedures, run by Mahidol University at 1 site in Thailand.
Trial summary
This study is a retrospective work involving the review of patients who were scheduled for VP or LP shunt in Siriraj Hospital, Mahidol University, Thailand. The sample size calculation was based on the rule of thumbs of the logistic regression comprising 18 risk factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The iNPH Patients Scheduled for VP or LP Shunt Procedures
- What is being tested?
- Ehedrine Norepineprine
- How many people
- 426 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2021to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Elective cases of iNPH scheduled for VP and LP shunt whose medical records were acquired from the hospital's central database.
Who may be able to join
- Elective cases of iNPH scheduled for VP and LP shunt
- Patients aged > 18 years old
Who cannot join
- Emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Post-induction Hypotension in Idiopathic Normal Pressure Hydrocephalus (iNPH) Patient Undergoing Ventriculoperitoneal (VP) and Lumbar Peritoneal (LP) Shunt
This study is a retrospective work involving the review of patients who were scheduled for VP or LP shunt in Siriraj Hospital, Mahidol University, Thailand. The sample size calculation was based on the rule of thumbs of the logistic regression comprising 18 risk factors. The incidence of post-induction hypotension according to our institution's pilot study November 2019-January 2020) was 47%. With 10% addition for missing data and other possible reasons, the sample size was 426. The primary objective of the study is to report the factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures. Our secondary objective is to determine the incidence of post-induction hypotension in these patients.
- Being tested
- Ehedrine Norepineprine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ehedrine NorepineprineDrug
No interventions required considering that this was a retrospective study.
| Study group | Role | What they receive |
|---|---|---|
| Hypotensive group | Hypotenson is defined as systolic blood pressure (SBP) < 80 mmHg or a drop more than 20% from baseline SBP for longer than 10 minutes or a drop that requires treatment either vasopressor or inotropic drugs. Receives: Drug: Ehedrine Norepineprine | |
| Non-hypotensive group | The pateints who did not develop hypotensive episodes as aforementioned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures
Risk factors associated with post-induction hypotension after administration of anesthetic agents
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jun 2021
- Primary completion30 Nov 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The iNPH Patients Scheduled for VP or LP Shunt ProceduresStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phuriphong Songarj, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183061
- Sponsor's protocol ID
- 961/2563(IRB4)
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Post-induction Hypotension in Idiopathic Normal Pressure Hydrocephalus (iNPH) Patient Undergoing Ventriculoperitoneal (VP) and Lumbar Peritoneal (LP) Shunt
- ClinicalTrials.gov ID
- NCT05183061
- Acronym / sponsor ID
- 961/2563(IRB4)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a retrospective work involving the review of patients who were scheduled for VP or LP shunt in Siriraj Hospital, Mahidol University, Thailand. The sample size calculation was based on the rule of thumbs of the logistic regression comprising 18 risk factors. The incidence of post-induction hypotension according to our institution's pilot study November 2019-January 2020) was 47%. With 10% addition for missing data and other possible reasons, the sample size was 426. The primary objective of the study is to report the factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures. Our secondary objective is to determine the incidence of post-induction hypotension in these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotensive group | – | Drug: Ehedrine NorepineprineHypotenson is defined as systolic blood pressure (SBP) < 80 mmHg or a drop more than 20% from baseline SBP for longer than 10 minutes or a drop that requires treatment either vasopressor or inotropic drugs. |
| Non-hypotensive group | – | –The pateints who did not develop hypotensive episodes as aforementioned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Elective cases of iNPH scheduled for VP and LP shunt whose medical records were acquired from the hospital's central database.
Key inclusion criteria (2 listed)
- Elective cases of iNPH scheduled for VP and LP shunt
- Patients aged > 18 years old
Key exclusion criteria (1 listed)
- Emergency cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ehedrine NorepineprineNo interventions required considering that this was a retrospective study. | Drug | Hypotensive group |
Primary outcome
Factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures
Time frame: 9 months
Risk factors associated with post-induction hypotension after administration of anesthetic agents
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The iNPH Patients Scheduled for VP or LP Shunt Procedures, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.